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Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF (RECONNECT)

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PVI
PVI + SVC
Sponsored by
AZ Sint-Jan AV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 18 years
  • Patients scheduled for a repeat ablation of PAF after a previous PVI
  • PV reconnection (in ≥1 PV's) found during procedure at the time of randomization

Exclusion Criteria:

  • Patients with persistent AF
  • Patients with durable PVI (no PVR)
  • Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
  • Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
  • Left ventricular ejection fraction <35%.
  • Cardiac surgery within the previous 90 days.
  • Expecting cardiac transplantation or other cardiac surgery within 180 days.
  • Coronary PTCA/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
  • Documented history of a thromboembolic event within the previous 90 days.
  • Diagnosed atrial myxoma.
  • Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
  • Women who are pregnant or who plan to become pregnant between signing the informed consent form and the index ablation.
  • Acute illness or active infection at time of index procedure
  • Advanced renal insufficiency
  • Unstable angina.
  • History of blood clotting or bleeding abnormalities.
  • Contraindication to anticoagulation.
  • Life expectancy less than 1 year.
  • Presence of a condition that precludes vascular access.
  • INR greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
  • Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
  • Unwilling or unable to provide informed consent.

Sites / Locations

  • AZ Sint-Jan Brugge-Oostende AVRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PVI only group

PVI + SVC group

Arm Description

Patients allocated to this group will receive PV re-isolation alone

Patients allocated to this group will receive PV re-isolation with SVC isolation.

Outcomes

Primary Outcome Measures

Recurrence of atrial tachyarrhythmia 1 year after the index ablation
Measured on 72hr Holter monitoring
Safety measured by procedural complications
Occurence of procedural complications post procedure

Secondary Outcome Measures

Total procedure time
Difference in total procedure time between groups
Fluoroscopy time
Difference in fluoroscopy time between groups
RF ablation time
Difference in RF ablation time between groups
Atrial volume
Evaluation of the atrial volume (ml)
SVC width
Evaluation of the SVC width (mm)
phrenic nerve width
Evaluation of the phrenic nerve width (mm)

Full Information

First Posted
October 20, 2020
Last Updated
August 2, 2022
Sponsor
AZ Sint-Jan AV
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1. Study Identification

Unique Protocol Identification Number
NCT04602169
Brief Title
Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF
Acronym
RECONNECT
Official Title
Added Value of Superior Vena Cava Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Redo procedures after CLOSE-guided pulmonary vein isolation (PVI) for atrial fibrillation (AF) occur in 10% of patients. In case of pulmonary vein (PV) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known PV-triggers. The superior vena cava (SVC) is one of the most common non PV-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency-ablation under close monitoring of the phrenic nerve. However, it's added value remains unclear. With this prospective, randomized, controlled, unblinded, mono-center study, the investigators aim to evaluate the 1-year recurrence rate in paroxysmal AF patients with reconnected pulmonary veins during a redo ablation with PV re-isolation or PV re-isolation with SVC isolation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PVI only group
Arm Type
Active Comparator
Arm Description
Patients allocated to this group will receive PV re-isolation alone
Arm Title
PVI + SVC group
Arm Type
Active Comparator
Arm Description
Patients allocated to this group will receive PV re-isolation with SVC isolation.
Intervention Type
Procedure
Intervention Name(s)
PVI
Intervention Description
PV re-isolation will be conducted according to the CLOSE-protocol. Point-by-point radiofrequency (RF) delivery will be performed aiming for a contiguous circle enclosing all PVs. RF will be delivered in a power-controlled mode (without ramping) using 35-40 Watt. The irrigation rate will be set at 30 ml/min. RF will be delivered until an ablation index (AI) of ≥400 is reached at the posterior wall and ≥550 at the anterior wall. In case of dislocation, a new RF application reaching the AI target will be applied. Maximal intertag distance between two neighboring lesions is 6 mm. In case of intra-esophageal temperature (T°) rise >38.5°C during posterior LA wall ablation, RF delivery will stopped at an AI of 300. In the absence of first pass isolation, touch-up ablation was applied until PVI. In case of reconnection during the waiting time or during the adenosine test, the site of reconnection will be located and treated with touch-up ablation until adenosine proof PVI is reached.
Intervention Type
Procedure
Intervention Name(s)
PVI + SVC
Intervention Description
Patients in this group receive PVI according to the CLOSE protocol. In addition, they will receive an SVC isolation. The circular mapping catheter will be introduced in the superior vena cava to determine baseline electrical activity and to confirm definite entrance and exit block after ablation. Ablation will be performed proximally to the SVC/right atrial junction with the contact force-catheter using circular point-by-point radiofrequency delivery with a power setting of 35W, targeting an AI ≥400. High output (25 mA) pacing will be applied before each RF application to check for phrenic nerve stimulation. In areas of phrenic nerve capture ablation will be avoided even in case of incomplete isolation.
Primary Outcome Measure Information:
Title
Recurrence of atrial tachyarrhythmia 1 year after the index ablation
Description
Measured on 72hr Holter monitoring
Time Frame
1 year after ablation
Title
Safety measured by procedural complications
Description
Occurence of procedural complications post procedure
Time Frame
From time of ablation to 1 month post procedure
Secondary Outcome Measure Information:
Title
Total procedure time
Description
Difference in total procedure time between groups
Time Frame
At time of ablation
Title
Fluoroscopy time
Description
Difference in fluoroscopy time between groups
Time Frame
At time of ablation
Title
RF ablation time
Description
Difference in RF ablation time between groups
Time Frame
At time of ablation
Title
Atrial volume
Description
Evaluation of the atrial volume (ml)
Time Frame
At time of ablation
Title
SVC width
Description
Evaluation of the SVC width (mm)
Time Frame
At time of ablation
Title
phrenic nerve width
Description
Evaluation of the phrenic nerve width (mm)
Time Frame
At time of ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years Patients scheduled for a repeat ablation of PAF after a previous PVI PV reconnection (in ≥1 PV's) found during procedure at the time of randomization Exclusion Criteria: Patients with persistent AF Patients with durable PVI (no PVR) Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI. Left ventricular ejection fraction <35%. Cardiac surgery within the previous 90 days. Expecting cardiac transplantation or other cardiac surgery within 180 days. Coronary PTCA/stenting within the previous 90 days or myocardial infarction within the previous 60 days. Documented history of a thromboembolic event within the previous 90 days. Diagnosed atrial myxoma. Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment Women who are pregnant or who plan to become pregnant between signing the informed consent form and the index ablation. Acute illness or active infection at time of index procedure Advanced renal insufficiency Unstable angina. History of blood clotting or bleeding abnormalities. Contraindication to anticoagulation. Life expectancy less than 1 year. Presence of a condition that precludes vascular access. INR greater than 3.5 within 24 hours of procedure - for patients taking warfarin. Patient cannot be removed from antiarrhythmic drugs for reasons other than AF. Unwilling or unable to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Lycke, MSc, PhD
Phone
003250453293
Email
michelle.lycke@azsintjan.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Knecht, MD, PhD
Organizational Affiliation
AZ Sint-Jan AV
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
State/Province
Please Select
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Lycke, MSc, PhD
Phone
00 32 45 32 93
Email
michelle.lycke@azsintjan.be

12. IPD Sharing Statement

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Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF

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